Summary

Eligibility
for people ages up to 6 months (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around

Description

Summary

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

Official Title

Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

Details

Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab 0.25 mg. Study exams will be at 1 day, 4 days (if no improvement on day 1), 1, 2, 3, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 and 12 months. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success within each dose group, defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractive outcomes, and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups.

Keywords

Retinopathy of Prematurity, Retinal Diseases, Premature Birth, Bevacizumab, Bevacizumab- 0.063 mg, Bevacizumab- 0.25 mg

Eligibility

Locations

  • Univ of California, Irvine- Gavin Herbert Eye Institute accepting new patients
    Irvine California 92697 United States
  • Jules Stein Eye Institute at the University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jaeb Center for Health Research
Links
PEDIG Public Website
ID
NCT04634578
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated